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Form of work*Title: Quality Lab Associate *
*Location: Hayward, CA*
*Duration: 6 months*
*Summary*
Quality Inspector reports into the Quality Inspection team within the broader Quality Operations department. The Inspector will be primarily responsible for ensuring Quality Finished Goods Inspection and/or Quality Raw Materials Inspection support is available to Manufacturing whenever necessary without interrupting Manufacturing operations. The Inspector may also perform general Quality Operations duties.
*Essential Duties and Responsibilities*
*Inspection Team:*
* Responsible for the inspection and verification activities in the manufacturing process. Must always adhere to current Good Manufacturing Practices (cGMPs)
* Inspection and release of raw materials, in-process materials and components, and finished goods.
* Verify various manufacturing steps and techniques.
* Tagging and de-tagging of discrepant material.
* Release of packaged product into warehouse.
* Maintenance and disposal of quality retains.
* Control and verification of patient labels.
* Archiving of quality records.
*General Quality Duties*
* Closely monitors production lines and personnel to verify compliance to specifications and Good Manufacturing Practices (GMP) requirements.
* Conducts final packaging inspections of final product and documents results in appropriate manner.
* Interacts with appropriate departments to ensure product quality issues are resolved prior to final product release.
* Monitors and ensures proper segregation and identification practices during manufacturing or rework processes.
* Must be able to effectively communicate across all departments and levels of management.
* Other duties, as assigned.
*Qualifications*
* Thorough knowledge of applicable procedures, specifications, regulations and standards.
* Ability to manage / supervise a large team of employees.
* Strong analytical and problem-solving skills.
* Strong communication and leadership skills.
* Strong interpersonal, communication, influencing, negotiation skills.
* Strong time / project management skills.
*Education and/or Experience*
* Bachelor’s degree or
* Associate degree with 1-2 years related experience or
* High School diploma with 2-4 years related experience.
* Experience in a pharmaceutical, medical device, bioscience, or other FDA-regulated environment required.
* Must be familiar with cGMP and FDA requirements.
* Knowledge of aseptic techniques is helpful.
* Must have strong computer/data skills.
*Physical Demands*
* Regular attendance is necessary to perform the essential functions of the job.
* Frequent lifting up to 40 lbs; frequent standing/walking.
*Working Environment*
* Normal office working conditions: computer, phone, files, fax, copier.
* Personal Protective Equipment: As applicable
* Routine work within a manufacturing environment (manufacturing process equipment, utilities, etc.) and a warehouse environment (forklifts, pallet jacks, etc.)
* Required use of standard warehouse/manufacturing equipment and tools for accessing lots in need of inspection (e.g., pallet jacks, safety razors, etc.)
* May be requested to receive training/certification for forklift usage
Job Type: Contract
Pay: $24.00 - $26.00 per hour
Benefits:
* Dental insurance
* Health insurance
* Life insurance
* Referral program
Schedule:
* Monday to Friday
Work setting:
* In-person
Application Question(s):
* How many years of Quality Lab experience do you have?
* Are you familiar with GMP and FDA requirements?
Work Location: In person
